Sodium Stibogluconate Treatment of Leishmaniasis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00662012|
Recruitment Status : Completed
First Posted : April 21, 2008
Results First Posted : March 9, 2017
Last Update Posted : March 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Leishmaniasis||Drug: Sodium Stibogluconate (SSG)||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||414 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sodium Stibogluconate Treatment of Leishmaniasis|
|Study Start Date :||June 2002|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||December 2007|
Experimental: Sodium Stibogluconate (SSG) 20 mg/kg
All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG.
Drug: Sodium Stibogluconate (SSG)
100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days.
Other Name: Pentostam (GlaxoSmithKline)
- The Primary Safety Endpoint - Frequency of Complications of Therapy [ Time Frame: 5 years ]The primary safety endpoint is the frequency of complications of therapy
- Improvement of Lesions, Resolution of Fever and Lab Abnormalities for Visceral Leishmaniasis and Regression of Mucosal Lesions . [ Time Frame: 5 years ]Improvement of lesions for cutaneous leishmanias, resolution of fever and lab abnormalities for visceral leishmaniasis and regression of mucosal lesions for mucocutaneous disease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00662012
|United States, District of Columbia|
|Walter Reed Army Medical Center|
|Washington, District of Columbia, United States, 20307|
|Principal Investigator:||Glenn Wortmann, MD||Walter Reed Army Medical Center, Infectious Disease|